Definition: Automatically Mark Electroencephalograph And Polysomongraph Signals In Order To Aid In Identification Of Such Events And Annotation Of Prolonged PSG Traces; Automatically Calculate Simple Measures Obtained From Recorded Signals (e.G. Magnitude, Time,
| Device Type ID | 3771 |
| Device Name | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Physical State | Electroencephalograph Analysis Software. Does NOT Include Electrodes, Electroencephalograph Hardware, Polysomnograph Hardware, Or Basic Electroencephalograph/polysomnograph Software (e.g. Used To Display, Store, Archive, Or Manually Annotate Data). |
| Technical Method | Uses Software Algorithms To Analyze Electroencephalograph And Polysomnograph Waveforms And Automatically Identify Areas Of Interest To The User |
| Target Area | Brain |
| Regulation Description | Electroencephalograph. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.1400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OLZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3771 |
| Device | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Product Code | OLZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electroencephalograph. |
| CFR Regulation Number | 882.1400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED BRAIN MONITORING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ENSODATA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NATUS MEDICAL INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RESPIRONICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |